Early Antibiotic Therapy and Vaccination

Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04109833

Enrollment

Registered

2019-09-30

Start date

2019-09-27

Completion date

2021-10-31

Last updated

2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccination Reaction

Brief summary

Neonatal Sepsis is one of the most common causes of death in preterm infants. Therefore, up to 80% of very low birth weight infants receive antibiotic therapy in their first week of life. Antibiotic therapy is one of the most important influencing factors for the establishment of the intestinal microbiome, which in turn modulates neonatal immune development. In this pilot study, it will be investigated, if antibiotic therapy in the first week of life influences the vaccination response of preterm infants.

Detailed description

The aim of the study is to compare antibody titers against Hepatitis B, Polio, Pertussis, Haemophilus influenza B, Tetanus, Diphteria and Pneumococcus in very low birth weight infants (VLBWI) infants who received antibiotic therapy in their first week of life and who did not. In this pilot study, 20 VLBWI infants will be included (10 per group). Infants will be matched fo age and gender.

Interventions

DRUGABT

any antibiotic therapy in the first week of life

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

24 Weeks to 28 Weeks

Healthy volunteers

Yes

Inclusion criteria

* born at University Hospital Tübingen * at least one dose of antibiotics within the first week of life

Exclusion criteria

* genetic disorders * chronic infections * hematological disorders * immunoglobulins within the first 60 days of life * immunological disorders * infants from Hepatitis B positive mothers

Design outcomes

Primary

Measure	Time frame	Description
vaccination reaction	7 months	measurement of antibody titers for Hepatitis B, Polio, Pertussis, Haemophilus Influenza B, Tetanus, Diphteria and Pneumococcus 4 months after the first vaccination (at an age of 6 months)

Secondary

Measure	Time frame	Description
Microbiome composition	7 months	microbiome analyses of stool samples at age 14 days and corrected 4 months

Countries

Germany

Contacts

Primary ContactNatascha Köstlin-Gille, Dr. med.

natascha.koestlin@med.uni-tuebingen.de0049-7071-2984743

Backup ContactChristian Gille, Dr. med.

christian.gille@med.uni-tuebingen.de0049-7071-83972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026